Global Safety Officer

CTI Clinical Trial and Consulting Services; Addlestone; Hybrid; GBP 50,000 - 75,000; Full time

Job summary

A leading global pharmaceutical company seeks a Global Safety Officer to enhance patient safety and advance healthcare. This full-time role involves proactive safety surveillance of drug products and collaboration with cross-functional teams, making a significant impact on patient lives. The position offers a hybrid working model with opportunities for personal and professional development.

Benefits

Opportunity for continuous development

Inspiring work climate

Qualifications

• Extensive experience in the pharmaceutical industry or health science setting.
• Strong understanding of safety regulations and regulatory requirements.
• Proven ability to influence decisions related to patient safety.

Responsibilities

• Lead pharmacovigilance Product Responsible Teams for effective safety surveillance.
• Identify and communicate emerging safety issues to relevant stakeholders.
• Design safety surveillance strategies and manage safety signals.

Skills

Communication

Regulatory Knowledge

Safety Surveillance

Education

Medical doctorate or advanced professional degree

Job description

Description

Global Safety Officer

About Astellas

At Astellas we are making treatments that matter to people.

We are tackling the toughest health challenges putting the patient at the heart of every move we make.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.

We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.

From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.

The Opportunity

At Astellas Pharma, you will play a pivotal role in enhancing patient safety and advancing healthcare. As the Global Safety Officer, you will be responsible for proactive safety surveillance of Astellas drug products, both in development and marketed. You will collaborate with crossfunctional teams to ensure robust medical safety surveillance and risk management activities, ultimately contributing to our mission of "Changing Tomorrow".

Your work will directly impact the lives of patients worldwide, making this an exciting opportunity to build your career on purpose and innovation.

Hybrid Working

At Astellas, we recognise that our employees enjoy having a balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

You will be part of an inclusive team that works to develop innovative therapies for patients.

Key Activities For This Role

• Lead pharmacovigilance (PV) Product Responsible Teams for assigned products, ensuring effective safety surveillance.
• Co-chair Global Development Safety Management Teams and participate in Global Development Core Teams.
• Identify and communicate emerging safety issues and updates to the Company Core Data Sheet and product Investigator’s Brochure.
• Design safety surveillance strategies and manage safety signals for Astellas products.
• Author and review safety evaluation reports, collaborating closely with the PV Scientist.
  
  

Essential Knowledge & Experience

• Extensive experience in the pharmaceutical industry or a relevant health science setting.
• Strong understanding of safety regulations for both marketed and investigational products.
• Excellent knowledge of regional and global regulatory requirements, including ICH guidelines.
• Proven ability to influence decisions related to patient safety and benefit-risk assessment.
• Strong communication skills, fostering open dialogue within teams and with key stakeholders.
  
  

Preferred Experience

• Medical doctorate or advanced professional degree in a scientific or health-related field (e.g., PharmD or PhD) is strongly preferred.
• Direct experience in pharmacovigilance or clinical development is advantageous.
• Familiarity with risk management strategies and safety signal detection tools.
  
  

Education

• Medical doctorate or advanced professional degree in a scientific or health-related field, or equivalent.
  
  

Additional Information

• This role is full-time permanent.
• This role is located in the UK office (Addlestone).
• This position follows our hybrid working model. The role requires a blend of home and minimum 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
  
  

What We Offer

• A challenging and diversified job in an international setting.
• Opportunity and support for continuous development.
• Inspiring work climate.
  
  

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Addlestone